What is the permissible overage (excess) of API in drug product formulation. Is there a reference for these limits? and what about vitamins, I found some vitamins formulation containing 25% excess amount.
According to USP the assay limit for Oral Suspension (Dry syrup) is 90- 120 %. In our formulation we had 10 % Overages. How can we justify the overages since there is no variability in manufacturing and testing method (system suitability RSD less than 2%).
Can we put overages based on assay limit which is higher than usual limit (90-110 %) ?
but i thought overage based on degradation was only allowed with Vitamins products. Does it also apply for antibiotic products such as cefixime in Dry syrup form? Can anyone point out some regulatory guidance which clarifies overage incorporation? Cefixime has assay range 90-120 %.